Trial record 15 of 24 for:
"Chordoma"
Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00349024
First received: July 5, 2006
Last updated: July 1, 2009
Last verified: June 2009
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Purpose
RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis, or mouth sores, in patients undergoing treatment for cancer.
PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Chordoma Kidney Cancer Leukemia Lymphoma Mucositis Neuroblastoma Pain Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: polyvinylpyrrolidone-sodium hyaluronate gel |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07) |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Kidney Cancer
Leukemia
Lymphoma
Neuroblastoma
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Timing and intensity of oral pain
- Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
- Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
- Symptoms, other than pain, considered important to the pediatric population
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy.
OUTLINE: This is a prospective, uncontrolled, open-label, pilot, multicenter study.
Beginning before hospital discharge or day 3 after chemotherapy, patients use oral polyvinylpyrrolidone-sodium hyaluronate gel mouth rinse for at least 1 minute, 3 times per day or as needed. Treatment continues for 48 hours. Patients with persistent oral pain may continue treatment with polyvinylpyrrolidone-sodium hyaluronate gel beyond 48 hours.
Oral pain and acceptability (i.e., taste) of polyvinylpyrrolidone-sodium hyaluronate gel are assessed periodically using self-reported rating scales.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 4 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of cancer, including, but not limited to, the following:
- Acute lymphoblastic leukemia
- Acute myeloid leukemia
- Brain tumor
- Hodgkin's lymphoma
- Non-Hodgkin's lymphoma
- Sarcoma
- Wilms' tumor
- Neuroblastoma
Meets 1 of the following criteria:
- Admitted to an in-patient unit after undergoing chemotherapy that is anticipated to cause oral mucositis
- Admitted to an in-patient unit after undergoing myeloablative therapy followed by peripheral blood stem cell or bone marrow transplantation
- Is experiencing oral pain due to mucositis
PATIENT CHARACTERISTICS:
- No known hypersensitivity to polyvinylpyrrolidone-sodium hyaluronate gel
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent analgesics allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349024
Locations
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| Middlesex Hospital | |
| London, England, United Kingdom, W1T 3AA | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
| Investigator: | Faith Gibson, MD | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Investigator: | Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F | Christie Hospital NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00349024 History of Changes |
| Other Study ID Numbers: | CDR0000481526, CCLG-SC-2005-07, EU-20621 |
| Study First Received: | July 5, 2006 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
chordoma unspecified childhood solid tumor, protocol specific pain childhood acute lymphoblastic leukemia childhood Hodgkin lymphoma chondrosarcoma osteosarcoma childhood soft tissue sarcoma Wilms tumor and other childhood kidney tumors neuroblastoma childhood acute myeloid leukemia/other myeloid malignancies childhood large cell lymphoma childhood lymphoblastic lymphoma childhood small noncleaved cell lymphoma childhood rhabdomyosarcoma |
childhood brain stem glioma childhood central nervous system germ cell tumor childhood cerebellar astrocytoma childhood cerebral astrocytoma/malignant glioma childhood choroid plexus tumor childhood craniopharyngioma childhood ependymoma childhood medulloblastoma childhood meningioma childhood oligodendroglioma childhood atypical teratoid/rhabdoid tumor childhood spinal cord neoplasm childhood supratentorial primitive neuroectodermal tumor childhood visual pathway and hypothalamic glioma mucositis |
Additional relevant MeSH terms:
|
Chordoma Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Nervous System Neoplasms Neuroblastoma Stomatitis Central Nervous System Neoplasms Mucositis Sarcoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neoplasms, Germ Cell and Embryonal Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial |
ClinicalTrials.gov processed this record on May 23, 2013